Medicines Safety Flashcards
Side effects: VERY Common definition?
1 in 10
Side effects: common definition?
1 in 100 to 1 in 10
Side effects: Uncommon definition?
1 in 1000 to 1 in 100
Side effects: Rare definition?
1 in 10,000 to 1 in 1000
Side effects: Very rare definition?
Less than 1 in 10,000 experience this
Class 1 MHRA defective medicines alert: requires action within?
24 hours
Immediate recall: because the product poses a serious or life threatening risk to health
Class 2 MHRA defective medicines alert: requires action within?
48 hours
the defect could harm the patient but is not life threatening
Class 3 MHRA defective medicines alert: requires action within?
5 days
the defect is unlikely to harm patients and is being carried out for reasons other than patient safety.
Class 4 MHRA defective medicines alert: requires action within?
Means caution in use only
indicates that the product poses no threat to patient safety
By law, manufacturers must report to the MHRA any important defects in both medicines and medical devices. What can Warnings/ Alerts be issued about?
Defective medicines
problems with devices
side effects associated with medicines and blood and blood products.
What does the black triangle mean?
Means this drug is recently on the market- so it prompts people that all ADR’s need to be reported with these drugs.
Usually kept for 5 years
Endocrine disorders Anaphylaxis Jaudine Heamorrhage Renal impairment Eye disorders fertility effects
Are all examples of what?
‘Serious’ reactions that must be reported to MHRA in all circumstances.
Any pro-longed hospitalisation, disabling, fatal, teratogenicity all must be reported.
Do all ADR’s in children have to be reported?
The BNF states they do!! ALL of them
What is Steven Johnsons Syndrome? What could cause it?
Severe hypersensitivity reaction:
Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips, but also in the genital and anal regions. Rash usually appears all over the body bar the scalp.
Drugs causing it examples: a lot of the anti-epileptics
Lamotrigine (most common!)
Phenytoin
Carbamazepine
What could cause brown staining of the teeth?
Most common cause: Chlorhexidine mouthwash
Iron salts
Intrinsic staining: tetracyclines (usually only in children)
Osteonecrosis of the jaw can results from Bisphosphonate use. This is more common with IV or Oral?
IV
But all patients on bisphosphonates should have a dental check-up
What drug can cause gingival hyperplasia (gum enlargement)?
Phenytoin
also less commonly Nifedipine and ciclsporin
Drugs which may cause taste disturbance?
metformin terbinafine (antifungal) lithium ACE inhibitors amiodarone metronidazole
What is the definition of an unlicensed medicine?
A product that does not hold a marketing authorisation/ license for use in the UK. These medicines will not appear in the BNF because the BNF only lists products with a MA, they will only be made up in specials manufacturing units/ imported from other countries
Be careful: the product itself may be listed but the specific strength you’re after is not: this would still be a special/ unlicensed
What is the definition of an off-label medicine?
The medicine has a UK marketing authorisation but it is being used for a different indication to that which it is marketed for. This will be stated under the ‘unlicensed use’ heading in the monograph: states “Not licensed for use in…” This does not mean it’s a unlicensed product, just means it’s being used for a condition out of its licensing
What is a licensed medicine?
A medicine that has a UK marketing authorisation, at that strength, that is being used for a condition it’s MA covers
What laboratory test is needed to confirm someone is suffering from a hypersensitivity reaction?
Full Blood Count and differential- to look for presence of IgE?
If you want to work out the bioavailability of a drug as an Oral Modified release prep, immediate release prep, oral solution etc, what should you always compare against?
Bioavailability of the drug as a parenteral solution given by IV bolus or IV infusion- this would show its complete absorption bioavailability
Medication errors, especially those that have gone out to the patient, even if they do not cause harm, should be reported to who?
NRLA- national reporting and learning system
In the case of an anaphylactic reaction, where should adrenaline auto-injector pens be administered?
Outer thigh!
NB: the MHRA advise that an ambulance is called after every use of an auto-injector, even if symptoms are improving
When must the herbal remedy Echinacea be avoided, and why?
Should not be given to children under 12 years due to risk of severe allergic reaction outweighing any benefits
What is DRESS syndrome and what drugs may cause it?
Drug Rash with Eosinophilia and Systemic Symptoms. Characterised by rash, fever and patients should be advised to stop taking medication and seek medical attention.
Carbamazepine (+ Steven Johnsons)
Oxcarbazepine
Esilcarbazepine
Strontium (a bisphosphonate)
The risk of serious skin related adverse drug reactions occurring with Carbamazepine (plus Oxcarbazepine and Esilcarbazepine) may be increased by the HLA-A*3101 allele found in patients of what ethnicity?
European
Japanese
If a patient has an allergy, whether it be to a drug or to nuts or a food, what coloured wristband should they have in hospital?
Red
Which anti epileptic from the following should be used in a patient with Antiepileptic Hypersensitivity syndrome (AHS): Carbamazepine Phenytoin Sodium Valproate Lamotrigine Oxcarbazepine
Sodium Valproate! Safest in AHS
AHS is rare but potentially fatal, and can occur with carbamazepine, lamotrigine, oxcarbazepine, phenytoin, phenobarbital and primidone.
Sodium Valproate and gabapentin and Benzo’s are considered safe.
A patient takes the following medication:
Diazepam
Atenolol
Erythromycin
Captopril
They have developed Angioedema, swelling of the skin due to fluid build up with a hives like rash. Which medication is this likely to have been caused by?
Captopril
ACE inhibitors can cause angioedema, thought to be caused by the build up of bradykinin. Afro-carribean and black american patients are up to 4x more likely to get this.
A woman has a rupture in her achilles tendon, which drug is this likely to be down to:
Ramipril Ciclsporin Flupentixol Ciprofloxacin Bezafibrate
Ciprofloxacin
Quinolone antibiotics (Ciprofloxacine, Levofloxacin) have been associated with TENDONITIS
